Orthotic insert for decreased forefoot loading

ABSTRACT

The present teachings provide orthotic inserts, methods of employing the same, and footwear comprising the same, for decreased forefoot loading. The insert can be configured to-fit in a footware such as a surgical boot or other footwear. The inserts are useful in any application in which decreased forefoot loading is desirable. The insert can be used as an adjunct in the healing of and pain relief from various medical conditions relating to the forefoot.

FIELD

The present disclosure generally relates to orthotic inserts, methods ofemploying the same, and footwear comprising the same, for decreasedforefoot loading.

BACKGROUND

The human foot is a complex bio-mechanical appendage that facilitateslocomotion by adapting to a variety of surfaces. By a series of complexkinematics, the foot acts initially as a shock absorber at heel strike,then as a mobile adapter during mid-stance, next as a rigid lever duringlate stance, and finally provides propulsion at toe-off. Forefoot anddigital maladies are common and difficult to protect during treatment,because patients often continue to walk, which carries with it forefootloading.

Some known treatments of forefoot and digital injuries include padding,cushioning, innersoles with and without cut-outs, surgical shoes and CAMwalkers, casts, crutches, and/or wheelchairs to facilitate protectivecomfort and immobilization. Other approaches have addressed the problemof guarded weight bearing by a plethora of cushioned supports.

U.S. Pat. No. 2,598,217 to Bronson describes a removable boot for aninvalid's foot and relies on a uniform rubber layer for cushioning withno appreciable gait altering mechanism. U.S. Pat. No. 5,078,128 to Grimet al. describes a removable leg walker with inflatable bladders thatrelies primarily on cushioning with immobilization to provide adequateprotection. U.S. Pat. No. 5,329,705 to Grim et al. describes a removableleg walker and bladders in conjunction with removable sectionscorresponding to the “injured” area. All these methodologies rely oncushioning for attempted pressure relief. The pocket accommodations donot, unfortunately, address the dynamic nature of human gait, and theconstantly changing moment of force that is dependent upon theparticular stage of gait and the foot's adaptation to ground reactiveforces.

U.S. Pat. No. 6,481,120 B1 to Xia et al. describes a standard shoeinsole for patients suffering from diabetes or arthritis, but alsorelies on cushioning rather than a true bio-mechanical altering device.U.S. Pat. No. 4,546,557 to Barouk et al. describes a shoe for patientshaving undergone a surgical operation on the forefoot, but does notprovide support to forefoot. U.S. Pat. No. 5,138,777 to Darby alsodescribes a shoe for patients having undergone a surgical operation onthe forefoot, but relies on a wedge undersole of triangular shape and amid-sole that has both flat top and bottom surfaces.

Unfortunately, with the increase of obesity and diabetes, associatedneuropathic disease is also on the rise. Neuropathic disease can lead toneurotrophic ulcers in the foot, which commonly progresses toosteomyelitis and need for costly hospitalization and life-alteringamputation. In the United States alone, in 2004, approximately 71,000lower extremity amputations occurred with people with diabetes, themajority of which were the result of forefoot and digital ulcerations.The International Diabetes Federation reports a lower extremityamputation occurs every 30 seconds worldwide. This trend isunsustainable, both morally and financially.

Whether due to injury, disease, or surgery, patients often experiencesignificant pain and/or healing complications when applying pressure tothe forefoot. Existing footwear and available orthotic inserts fail toprovide adequate relief in such situations. Pain, diminished mobility,and time away from both work and active recreational pursuits, causepatients physical and psychological trauma, while also adverselyaffecting patient productivity. Accordingly, a need exists for medicaldevices that provide diminished load to the forefoot, as well as,generally relieving foot pain and aiding in the healing of footpathologies.

SUMMARY

The devices, sets, and methods described herein address that need byproviding an orthotic insert for a footwear. The insert can comprise thefollowing elements. A top portion spans a length and a width of theinsert. A bottom portion spans the length and the width of the insert. Aheel portion begins at a back edge of the length of the insert and hasan average thickness comprising the top and bottom portions. A forefootportion terminates at a front edge of the length of the insert and hasan average thickness, comprising the top and bottom portions, that isgreater than the average thickness of the heel portion. A transitionportion, between the heel and forefoot portions, has an averagethickness, comprising the top and bottom portions, greater than theaverage thickness of the heel portion and less than the averagethickness of the forefoot portion, and is inclined from the heel portionto the forefoot portion. A footwear comprising the insert is alsoprovided. An orthotic insert set comprising two or more inserts isprovided. The set can provide left and right inserts, multiple leftinserts, multiple right inserts, or any combination thereof. Sets offootwear comprising sets of inserts are also provided. A method ofpreparing a footwear for minimizing pressure on a forefoot of a user isfurther provided. The method can comprise inserting an orthotic insertinto at least one footwear for a user.

According to various embodiments, an orthotic footwear device isprovided that blocks forefoot and digital loading by limiting motion.The device can include a thickened elastomeric forefoot and digitalcushion in an elevated platform configuration. According to variousembodiments, a biomedical device is provided for insertion intoprotective foot gear such as surgical shoes or CAM walkers. The devicecan temporarily support the human foot and be constructed in such amanner as to limit forefoot and digital loading thereby providingtreatment to injured skin, soft tissue, and bony structures. Whenforefoot and digital structures are compromised or injured, excessiveforefoot loading prevents healing and restoration of integrity to thesestructures. Indications for usage can include, but not be limited to,skin ulcerations, metatarsalgia, capsulitis, tendonitis, neuralgia,arthritis, and bony fractures either traumatic or surgical in origin.

It is one object of the present invention to provide a generic shoesize-dependent bio-mechanical blocking device easily fitted into asurgical shoe or CAM walker and that can be dispensed to patients as anadjunct to therapy in the treatment of forefoot and digital injuriesalbeit skin, soft tissue, and bony structures.

Another object of the present art is to substantially alter the transferof weight to the forefoot and digits by blocking and limiting mid-tarsaljoint motion and re-supination.

A further object of the present invention is to provide a forefootplateau to accept any residual loading that may occur, wherein theplateau can comprise a combination of a thickened elastomeric resilientlayer covered with a sheer dispersing material.

It is still a further object of the present art to provide aninexpensive, readily available aid that can be immediately dispensableat the time of a consultation. Further, and in the case of open wounds,the easily removable device can provide real time visual assessment byboth a healthcare practitioner and a patient, and can be particularlybeneficial in monitoring signs of potential infection. The decrease inforefoot loading is especially pertinent in the neuropathic/insensitivefoot where a protective sense of pain is greatly diminished or absentthereby reducing the probability of compliance.

Besides the obvious physical therapeutic advantages provided by thepresent teachings, the psychological benefits are at least equallybeneficial. As discussed, the difficulties with patient compliance withthe prior art is compromised, if not physically impossible, with theco-morbidities of the aged, obese, and the disabled. The psychologicalramification of noncompliance by the patient can damage self-image andpromote denial of the disease process, further reducing the probabilityof good outcomes. The present teachings allow for a real opportunity forcompliance and thereby allow the patient to become co-responsible and anactive participant in their own rehabilitation. Other objects andadvantages of the present invention will be pointed out specifically orwill become apparent from, and in conjunction with, the appended claimsand drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the accompanying drawings,which are intended to illustrate, not limit, the present teachings.

FIG. 1 is a front perspective view of an orthotic insert in accordancewith an embodiment of the present teachings.

FIG. 2A is a top view of the orthotic insert shown in FIG. 1.

FIG. 2B is a bottom view of the orthotic insert shown in FIG. 1.

FIG. 3A is a right side view of the orthotic insert shown in FIG. 1.

FIG. 3B is a left side view of the orthotic insert shown in FIG. 1.

FIG. 4A is a back view of the orthotic insert shown in FIG. 1.

FIG. 4B is a front view of the orthotic insert shown in FIG. 1.

FIG. 5 is a right side view of an orthotic insert according to variousembodiments of the present teachings, and a skeletal foot resting on theinsert.

FIG. 6 is a top view of the orthotic insert shown in FIG. 1 with askeletal foot resting on the insert.

DETAILED DESCRIPTION OF THE DISCLOSURE

The orthotic insert of the present teachings can support the human foot,while the foot is in a weight-bearing position, both in stance and/orfunctioning throughout gait in a manner that reduces forefoot loading ofthe metatarsal heads. This support can be accomplished by shifting theweight to the proximal metatarsal arch and thereby inhibiting forefootpronation and greatly reducing normal forefoot loading during the stanceand propulsive phase of gait.

According to various embodiments, the present teachings provide anorthotic insert for a footwear, an embodiment of which is shown byreference numeral 20 in FIG. 1 in an unbiased configuration, that is,without the weight of a foot applied to the insert. FIG. 1 shows aperspective view of insert 20 with FIGS. 2A, 2B, 3A, 3C, 4A, and 4B,showing bottom view, right side view, left side view, back view, andfront view, respectively. FIGS. 5 and 6 show a skeletal foot resting onthe insert from two different views. A left insert is shown in theFIGS., for illustrative purposes, but a right, mirror image, insert, isalso provided by the present teachings. A universal insert suitable forinsertion into either a left footwear, a right footwear, or both, isprovided.

Insert 20 can comprise a top portion 22 spanning a length and a width ofthe insert; a bottom portion 24 spanning the length and the width of theinsert; a heel portion 26 beginning at a back edge 28 of the length ofthe insert and having an average thickness comprising the top and bottomportions; a forefoot portion 30 terminating at a front edge 32 of thelength of the insert and having an average thickness, comprising topportion 22 and bottom portion 24, that is greater than the averagethickness of the heel portion; and a transition portion 34, between theheel and forefoot portions, having an average thickness comprising the,top and bottom portions, greater than the average thickness of the heelportion and less than the average thickness of the forefoot portion, andinclined from the heel portion to the forefoot portion.

The insert can comprise two or more layers, top portion 22 can comprisea first material 36, bottom portion 24 can comprise a second material38, and the first material can be softer than the second material. Forexample, top portion 22 and bottom portion 24 can intersect or meet atan intersection 35. Intersection 35 can delineate the bottom of topportion 22 and the top of bottom portion 24. For example, intersection35 can delineate where the first material 36 ends and where the secondmaterial 38 ends. A third material 37 can also be provided, for example,inside of the insert, as shown in phantom by the dashed line. Thirdmaterial 37 can be softer than second material 38. The first material,the second material, and the third material can comprise a foam, arubber, or any combination thereof. The foam can comprise an open cellfoam, a closed cell foam, or both. The first, second, and/or thirdmaterials can comprise elastomeric, polymeric, resilient, and othertypes of materials. Examples of materials for the first, second, andthird materials can comprise leather, leatherboard, fabric, wool,cotton, thermoplastic elastomers, polyester, polypropylene,polyethylene, polyurethane, polyurea, cellular urethane, polystyrene,latex, nylon, carbon or glass fibers with thermosetting or thermoplasticresins, plastizote, ethylene vinyl acetate (EVA) foams, expanded vinylfoam, flocked vinyl film, coagulated polyurethane, latex foam on scrim,supported polyurethane foam, polyurethane film,styrene-butadiene-rubber, acrylonitrile-butadiene, acrylonitrileterpolymers and copolymers, styrene-butadienestyrene,acrylonitrile-butadiene-styrene, polyvinyl chloride (PVC),ethylenepropylene rubber, silicone rubber (SiR), silicone elastomer,acrylic rubber (ACM), butadiene rubber (BR), butyl rubber (IIR),chlorosulfonated polyethylene (CSM)/hypalonthylene propylene dienemonomer (EPM, EPDM), fluoroelastomers (FKM), isoprene rubber (IR),nitrile rubber (NBR), perfluoroelastomer (FFKM), polychloroprene (CR),polysulfide rubber (PSR), styrene butadiene rubber (SBR), or anycombination thereof Third material 37 can be provided in a portion offorefoot portion 30 that comprises a cushioning substance, for example,a silica gel, and second material 38 can comprise EVA. One example of aposition for third material 37 is shown in FIGS. 2A, 3A, and 3B,however, the positioning of material 37 can be adjusted to provide asuitable cushioning support for the forefoot and/or other portions ofthe foot.

The orthotic device can comprise one or more of the materials described,for example, in U.S. Pat. No. 6,481,120 B1 to Xia et al., and U.S. Pat.No. 5,329,705 to Grim et al., which are incorporated herein in theirentireties by reference. Any PORON material may be used, for example, aPORON 4000 series material, a PORON 5015 material, a PORON 9612material, a combination thereof, and the like. For example, the orthoticinsert can be constructed of three basic materials. PORON, a cellularurethane available from Rogers Corporation of Rogers, Conn., is asemi-firm material that can run the entire length and base of the insertand provide stability and substrate for a supportive core. Thisconfiguration shifts the weight-bearing surfaces to the arch and therebylimits forefoot loading. PORON can extend upward as medial and lateralflanges (sidewalls) that can provide stability and prevent transversemotion of the forefoot to occur. These flanges can follow from about a 5degree to about a 50 degree, from about a 10 degree to about a 40degree, or from about a 20 degree to about a 30 degree rise and extendfrom about one eighth inch, from about one quarter inch, from about onehalf inch, from about three quarter inches, or from about one inchhigher than the top surface, thereby gently locking the mid-foot. As therise plateaus into a soft, flat cushioning surface for the metatarsalhead and digital regions, the side wall can blend into the forefootportion. PORON can also provide the substrate for other materials, suchas silicone gel in the form of an elastomere and a thin layer ofplastizote top covering, a protective cushion that is known to preventexcessive irritation and pressure in the insensitive foot.

Bottom portion 24 can comprise at least one arch region 40. The bottomportion can bend upwardly at back edge 28 providing an upwardly bentheel portion 42. The bottom portion, top portion, or both can beconfigured to provide arches and other geometries to accommodate theneed of a particular user.

Transition portion 34 can be inclined at an angle from about 10 degreesto about 80 degrees, from about 20 degrees to about 60 degrees, fromabout 25 degrees to about 50 degrees, or from 30 degrees to 40 degreesrelative to horizontal. The insert can be constructed in such a fashionwhere it is generally flat in the calcaneal (heel) region of the footand then angulated up between about 20 degrees to 30 degrees, or otherrange specified herein, to a rise of at least one eighth inch, at leastone quarter inch, at least one half inch, at least three quarter inches,or at least one inch, firmly supporting the entire metatarsal arch, thentransitioning to a soft cushion for the weight bearing areas of themetatarsal heads. Transition portion 34 can comprise at least one sidewall for centering a foot on the top portion of the insert. An outerside wall (flange) 44, an inner side wall (flange) 46, or both can beprovided. Transition portion 34 can comprise an outer region 48 alongthe top portion and an inner region 50 along the top portion, and outerregion 48 can have a greater angle of inclination than inner region 50.The average angle of inclination of outer region 48 can be from about0.5 degrees to about 25 degrees, from about 0.75 degrees to about 15degrees, from about 1 degree to about 10 degrees, and about 2 degrees toabout 5 degrees steeper than the average angle of inclination of innerregion 50.

The forefoot portion generally slopes downwardly, relative tohorizontal, from the transition portion to the front edge. The downwardslope can be less than about 1 degree, less than about 5 degrees, lessthan about 10 degrees, or less than about 25 degrees relative tohorizontal. The forefoot portion can have an average thickness fromabout 5% to about 5000%, from about 25% to about 2500%, from about 50%to about 1000%, from about 75% to about 750%, from about 125% to about500%, from about 150% to about 450%, from about 200% to about 400%, fromabout 250% to about 350%, or about 300% of the average thickness of theheel portion. The forefront portion can comprise from about 10% to about90%, from about 20% to about 80%, from about 30% to about 75%, or fromabout 45% to about 70% of the length of the insert, and the heel portioncan comprise from about 1% to about 75%, from about 5% to about 50%,from about 10% to about 40%, or from about 20% to about 35% of thelength of the insert. The forefoot portion can have an average width,the heel portion has and average width, and the average width of theforefoot portion is from about 100% to about 500%, from about 125% toabout 500%, from about 125% to about 400%, from about 150% to about350%, from about 150% to about 250%, from about 200% to about 300%, orgreater than about 500% of the average width of the heel portion.

In some embodiments, the orthotic insert can comprise a substrate orunitary layer which runs heel to toe and absorbs shock, partiallycontrols foot motion, and provides a lattice for the elastomeric andsheer resistive materials. Its bottom surface can be flat, interfacingand fitting contiguously with the upper layer of a surgical shoe or CAMwalker. The heel portion of the insert can be flat and horse-shoe shapedwhich secures the heel, the device, and a supportive shoe or walker as asingle functional unit. The mid-arch portion can rise abruptly convexlyin the sagittal plane at approximately a 30 to 50 degree angulation.This buttress can elevate dramatically distally in the entire transversetarsal arch region to just proximal to the panmetatarsal head region,limiting pronation, loading, and propulsion during gait and thusaffording forefoot and digital protection.

In some embodiments, the forefoot and digital component can flatten outinto a plateau and the device can become soft and accommodative. Theinsert can comprise one or more thick elastomeric layers. In some cases,the entire device from heel to toe can be covered by a protective topcover which prevents damaging sheer and frictional reactive forces. Theconvex mid-foot region can also have elevated medial and lateral flangesto prevent side to side transverse forefoot and digital motion. Theflanges can be comprised of the same semi-fine unitary substrate layeras the convex rise.

With respect to a surgical shoe or CAM walker, these typically arestand-alone devices, commonly used in post-traumatic or post-surgicalapplications. In some embodiments of the present teachings, the shoe orwalker secures the device to the foot by Velcro straps as a singlefunctional unit providing a weight bearing device that protects the footfrom varying external ground surfaces and liabilities.

In some embodiments, a footwear is provided comprising the orthoticinsert of the present teachings. Any type of footwear can be used withthe insert while accommodating the geometry of the insert. The footwearcan comprise a boot, a shoe, a sneaker, a sandal, a clog, or anycombination thereof. The orthotic insert can be made to fit into astandard type, flat surgical shoe, for example a surgical shoe availablefrom DARCO International, Inc. of Huntington, West Va. The orthoticinserts can be provided, distributed and/or sold separately, or aspre-inserted into a single or pair of footwear. The orthotic insert canbe made full or partial length from heel to toe. The orthotic insert canbe provided in different sizes, for example, extra-small, small, medium,large and extra-large to accommodate different size feet. The orthoticinsert can be provided in custom sizes. The orthotic insert can beprovided in sizes matching or compatible with standard shoe sizes suchas one or more of the shoe size systems employed in U.S., Canada,Mexico, Europe, Great Britain, Russia, the Ukraine, Australia, Japan,Korea, or elsewhere in the world.

The orthotic inserts can be provided with a graphic design in any coloror variety of colors, with or without letters, numbers, pictures, or anyother kind or combination of graphic elements. The graphic design of theinsert can be provided to match or complement that of a footwear inwhich it is inserted. Graphic design can also relate to any other orcombination of parameters such as foot size, insert thickness, and thelike.

According to various embodiments of the present teachings, incombination, an orthotic insert set comprising two or more inserts isprovided, each insert can comprise the following elements. A top portionspans a length and a width of the insert. A bottom portion spans thelength and the width of the insert. A heel portion begins at a back edgeof the length of the insert and has an average thickness comprising thetop and bottom portions. A forefoot portion terminates at a front edgeof the length of the insert and has an average thickness, comprising thetop and bottom portions, that is greater than the average thickness ofthe heel portion. A transition portion, between the heel and forefootportions, has an average thickness comprising the top and bottomportions, greater than the average thickness of the heel portion andless than the average thickness of the forefoot portion, and is inclinedfrom the heel portion to the forefoot portion. The two or more insertsof the combination set can comprise at least one insert having a leftfoot configuration and at least one insert having a right footconfiguration. In some embodiments, instead of a set, one or moreuniversal (compatible with both left and right feet) inserts can beprovided. In some embodiments, multiple left inserts, multiple rightinserts, or any combination thereof, can be packaged together. In someembodiments, a package comprising a single insert or one or more sets ofinserts can be provided.

According to various embodiments of the present teachings, a method ofpreparing a footwear for minimizing pressure on a forefoot of a user isprovided. The method can comprise inserting an orthotic insert into atleast one footwear for a user. The insert employed in the method cancomprise the following elements. A top portion spans a length and awidth of the insert. A bottom portion spans the length and the width ofthe insert. A heel portion begins at a back edge of the length of theinsert and has an average thickness comprising the top and bottomportions. A forefoot portion terminates at a front edge of the length ofthe insert and has an average thickness, comprising the top and bottomportions, that is greater than the average thickness of the heelportion. A transition portion, between the heel and forefoot portions,has an average thickness comprising the top and bottom portions, greaterthan the average thickness of the heel portion and less than the averagethickness of the forefoot portion, and is inclined from the heel portionto the forefoot portion. The method can comprise the step of placing afoot of a user in the prepared footwear. In accordance with the method,the insert can be inserted by anyone. For example, the insert can beinserted by the user; a family member; a medical professional such as asurgeon, an orthopedist, a physical therapist, a nurse, or a physician;a health care provider; a medical device manufacturer, distributor, orretailer or provider; a footwear retailer, distributor, or manufacturer;an orthotics retailer, distributor, or manufacturer; or any combinationthereof.

The orthotic insert can be used in any application where decreasedforefoot loading is desirable. The insert can be an adjunct in thehealing of neuropathic forefoot and digital ulcerations in theinsensitive foot, for forefoot metatarsalgia conditions such asbursitis/capsulitis, sesamoiditis, stress fractures, forefoot neuromas,and possibly fractures either posttraumatic or post-surgical in origin.The orthotic insert can be employed as a temporary adjunct for healingforefoot and digital, bone, soft tissue and skin injuries. As shown, forexample, in FIG. 5, the orthotic insert can be in contact with and liftthe base 53 of the metatarsal. In some embodiments, a foot would rest onthe orthotic insert in a configuration as shown in FIG. 6. In someembodiments, a method is provided that can comprise first performing asurgical operation on a forefoot of a user. The method can comprisediagnosing a foot malady of the user. The method can compriseidentifying a susceptibility to forefoot strain or damage in anindividual. The method can be coupled with one or more other methods fortreating, ameliorating, or preventing foot ailments, for example, thosecommonly associated with diabetes.

The orthotic insert, or set of inserts, can be used for any duration oftime from minutes, hours, days, months, or even years. The orthoticinsert can be worn from about 1 minute to about 1 year, from about 1hour to about 6 months, from about 12 hours to about 4 months, fromabout one day to about 3 months, from about 1 week to about 2 months,from about 2 weeks to about 1 month, or more than a year, or anycombination thereof. If left and right inserts are employed, each insertcan be worn for the same amount of time as the other or for differenttimes. For example, the orthotic insert can be used for several monthswhere prolonged protection and support is desirable.

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

While embodiments of the present disclosure have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the disclosure. It should beunderstood that various alternatives to the embodiments of thedisclosure described herein may be employed in practicing thedisclosure. It is intended that the following claims define the scope ofthe disclosure and that methods and structures within the scope of theseclaims and their equivalents be covered thereby.

1. An orthotic insert for a footwear, comprising: a top portion spanninga length and a width of the insert; a bottom portion spanning the lengthand the width of the insert; a heel portion beginning at a back edge ofthe length of the insert and having an average thickness comprising thetop and bottom portions; a forefoot portion terminating at a front edgeof the length of the insert and having an average thickness, comprisingthe top and bottom portions, that is greater than the average thicknessof the heel portion; and a transition portion, between the heel andforefoot portions, having an average thickness comprising the top andbottom portions, greater than the average thickness of the heel portionand less than the average thickness of the forefoot portion, andinclined from the heel portion to the forefoot portion.
 2. The orthoticinsert of claim 1, wherein the insert comprises two or more layers, thetop portion comprises a first material, the bottom portion comprises asecond material, and the first material is softer than the secondmaterial.
 3. The orthotic insert of claim 1, wherein the first materialis a foam and the second material is a rubber.
 4. The orthotic insert ofclaim 1, wherein the bottom portion comprises at least one arch region.5. The orthotic insert of claim 1, wherein the bottom portion bendsupwardly at the back edge.
 6. The orthotic insert of claim 1, whereinthe transition portion is inclined at an angle from 30 degrees to 40degrees relative to horizontal.
 7. The orthotic insert of claim 1,wherein the transition portion comprises at least one side wall forcentering a foot on the top portion of the insert.
 8. The orthoticinsert of claim 1, wherein the transition portion comprises an outerregion along the top portion and an inner region along the top portion,and the outer region has a greater angle of inclination than the innerregion.
 9. The orthotic insert of claim 8, wherein the average angle ofinclination of the outer region is from about 2 degrees to about 5degrees steeper than the average angle of inclination of the innerregion.
 10. The orthotic insert of claim 1, wherein the forefoot portiongenerally slopes downwardly, relative to horizontal, from the transitionportion to the front edge.
 11. The orthotic insert of claim 10, whereinthe downward slope is less than about 10 degrees relative to thehorizontal.
 12. The orthotic insert of claim 1, wherein the forefootportion has an average thickness, the heel portion has an averagethickness, and the average thickness of the forefoot portion is fromabout 125% to about 500% of the average thickness of the heel portion.13. The orthotic insert of claim 1, wherein the forefoot portion has anaverage width, the heel portion has an average width, and the averagewidth of the forefoot portion is from about 150% to about 250% of theaverage width of the heel portion.
 14. The orthotic insert of claim 1,wherein the forefront portion comprises from about 45 percent to about70 percent of the length of the insert and the heel portion comprisesfrom about 20 percent to about 35 percent of the length of the insert.15. A footwear comprising the orthotic insert of claim 1 insertedtherein.
 16. The footwear of claim 15, wherein the footwear comprises aboot.
 17. In combination, an orthotic insert set comprising two or moreinserts, each insert comprising: a top portion spanning a length and awidth of the insert; a bottom portion spanning the length and the widthof the insert; a heel portion beginning at a back edge of the length ofthe insert and having an average thickness comprising the top and bottomportions; a forefoot portion terminating at a front edge of the lengthof the insert and having an average thickness, comprising the top andbottom portions, greater than the average thickness of the heel portion;and a transition portion, between the heel and forefoot portions, havingan average thickness comprising the top and bottom portions, greaterthan the average thickness of the heel portion and less than the averagethickness of the forefoot portion, and inclined upward from the heelportion to the forefoot portion.
 18. The combination set of claim 17,wherein the two or more inserts comprise at least one insert having aleft foot configuration and at least one insert having a right footconfiguration.
 19. A method of preparing a footwear for minimizingpressure on a forefoot of a user, the method comprising: inserting anorthotic insert into at least one footwear for a user, the insertcomprising a top portion spanning a length and a width of the insert, abottom portion spanning the length and the width of the insert, a heelportion beginning at a back edge of the length of the insert and havingan average thickness comprising the top and bottom portions, a forefootportion terminating at a front edge of the length of the insert andhaving an average thickness, comprising the top and bottom portions,that is greater than the average thickness of the heel portion, and atransition portion, between the heel and forefoot portions, having anaverage thickness comprising the top and bottom portions, that isgreater than the average thickness of the heel portion, less than theaverage thickness of the forefoot portion, and inclined upwardly fromthe heel portion to the forefoot portion.
 20. The method of claim 19,further comprising: placing a foot of a user in the footwear preparedaccording to claim
 19. 21. The method of claim 19, further comprisingfirst performing a surgical operation on a forefoot of a user.
 22. Anorthotic insert for a footwear, comprising: a top portion spanning alength and a width of the insert; a bottom portion spanning the lengthand the width of the insert; a heel portion beginning at a back edge ofthe length of the insert and having an average thickness comprising thetop and bottom portions; a forefoot portion terminating at a front edgeof the length of the insert and having an average thickness, comprisingthe top and bottom portions, that is from about 150% to about 450% theaverage thickness of the heel portion; and a transition portion, betweenthe heel and forefoot portions, having an average thickness comprisingthe top and bottom portions, greater than the average thickness of theheel portion, and comprising an inner side wall and an outer side wallfor centering a foot on the top portion of the insert.